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Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension (ESMPPHTN)

R

Rania Ali El-Farrash

Status and phase

Completed
Phase 1

Conditions

Persistent Pulmonary Hypertension

Treatments

Drug: Milrinone
Drug: Sildenafil

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Compare the effect of milrinone versus sildenafil in treatment of neonates with persistent pulmonary hypertension.

Full description

40 neonates with PPHN, met inclusion criteria, randomly assigned to 2 groups, each includes 20, first group received intravenous milrinone and second group received nasogastric sildenafil. both groups receive other supportive care.

Enrollment

40 patients

Sex

All

Ages

1 hour to 10 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • gestational age >34 weeks
  • postnatal age <10 days

Exclusion criteria

  • neonates with congenital heart disease
  • neonates with congenital diaphragmatic hernia

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

milrinone
Active Comparator group
Description:
Milrinone is a phosphodiesterase inhibitor typ3 used in treatment of PPHN. used in dose (0.25 to 0.75 mg/kg/min) intravenous infusion compared with nasogastric sildenafil.
Treatment:
Drug: Milrinone
sildenafil
Active Comparator group
Description:
Sildenafil is a phosphodiesterase inhibitor typ 5 used in treatment of PPHN. used in dose (0.2 to 0.5 mg/kg/6h) by nasogastric tube compared with intravenous milrinone infusion.
Treatment:
Drug: Sildenafil

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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